Protocols

Acorda gets a badly needed PDUFA date with the FDA on Parkinson’s drug; Takeda signs neurological collaboration with antisense player Wave Life Sciences

Acorda $ACOR says that the FDA has finally accepted their application for Inbrija (CVT-301), putting their inhaled form of levodopa for Parkinson’s on track for a marketing decision by October 5. The regulatory advance comes 6 months after the agency initially refused to file their application, which now leaves the FDA due to make a decision by October. That’s a big deal at Acorda, as its last remaining patent protecting its big drug Ampyra is set to expire this summer, leaving them stripped of any legal armor against the generics that will shred that market. Acorda relies on Ampyra for almost all of its revenue.

Takeda has beefed up its neuroscience division with a four-year, multi-program option collaboration with Wave Life Sciences that covers research, development and commercialization. Antisense oligonucleotides for genetically defined neurological diseases is the overarching theme of the pact, which is broken down into two parts: the first involves the option to co-develop and co-commercialize certain programs currently undergoing clinical proof of mechanism, while the second gives Takeda the rights to exclusively license preclinical programs. Part 1 investigates therapies targeting Huntington’s disease, Lou Gehrih’s disease, frontotemporal dementia and spinocerebellar ataxia type 3; part 2 deals with other neurological disorders including Alzheimer’s and Parkinson’s.

→ Having formed strategic partnerships with Takeda Ventures in Japan and UCB Pharma in Belgium, Arix Bioscience has turned to China for its latest collaboration — with Hong Kong-listed Fosun International as its partner. The plan is to invest in and create new companies together on a broad range of new clinical therapies, with an emphasis on the growing Chinese market. Arix will provide access to its group businesses, pipeline and people network in exchange for Fosun’s knowledge of potential investment opportunities. Already teamed up with Kite in a joint venture, “Fosun’s extensive footprint and network in China will enhance Arix’s already strong sourcing power and provide our Group Businesses the opportunity of developing a deep relationship with a leading distribution partner in China,” said Arix CEO Joe Anderson.

Dynavax $DVAX has borrowed $175 million to launch the newly approved Heplisav-B. The biotech is getting a $100 million of that now from CRG and has $75 million available in a second tranche. The company reported that it had $192 million in cash at the end of last year.

→ Cullinan Oncology, the Cambridge, Massachusetts-based company that got $150 million in a Series A backing last October, is teaming up with Germany’s MAB Discovery GmbH to develop antibody therapeutics. “We are excited to enter into this collaboration as the MABD development engine provides us with access to highly differentiated monoclonal antibodies” said Patrick Baeuerle, Cullinan’s CSO, in a statement. “Our first program is a novel agonistic antibody that has the potential to be a pillar of future immuno-oncology and standard treatments.” The agreement does not provide for an upfront payment to MAB Discovery. Instead, MAB Discovery receives shares in an unknown amount to Cullinan’s subsidiary Cullinan Wittelsbach.


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